NYSE: PHGE

In our therapeutic programs, we focus on using
phage therapy to target specific strains of pathogenic bacteria that are associated with diseases. Our phage-based product candidates
are developed utilizing our proprietary research and development platform. Our platform is unique, employing cutting edge methodologies
and capabilities across disciplines including computational biology, microbiology, synthetic engineering of phage and their production
bacterial hosts, bioanalytical assay development, manufacturing and formulation, to allow agile and efficient development of natural or
engineered phage combinations, or cocktails. The cocktail contains phage with complementary features and is optimized for multiple characteristics
such as broad target host range, ability to prevent resistance, biofilm penetration, stability and ease of manufacturing.

Our goal is to develop multiple products based
on the ability of phage to precisely target harmful bacteria and on our ability to screen, identify and combine different phage, both
naturally occurring and created using synthetic engineering, to develop these treatments.

In December 2025, we discontinued the development
of our phage cocktail product for the treatment of Cystic Fibrosis or, BX004, following an internal analysis and feedback from the Data
Monitoring Committee, or DMC, which recommended consideration of alternative dosing regimens or treatment strategies in response to adverse
events experienced by certain participants; however, pursuing such alternatives was beyond the Company’s available resources. Additionally,
we implemented cost-cutting measures including a significant reduction in workforce while reviewing other strategic alternatives.

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In December 2025, following the discontinuation of the development
of BX004, our Israeli subsidiary, BiomX Ltd., commenced insolvency proceedings in Israel. Prior to the commencement of these insolvency
proceedings, BiomX Ltd. served as the core operational subsidiary of the Company, employing a significant portion of our workforce. As
a result of BiomX Ltd.’s insolvency, our business has been materially impacted, and without additional resources, we have limited ongoing
operations and limited ability to advance our programs as previously planned. Accordingly, we are actively evaluating and pursuing strategic
alternatives and other business opportunities to exploit the expertise of our management staff, based on time, available resources and
market conditions.

On December 26, 2025, the Company entered into
the 2025 Second SPA with the Investor. Pursuant to the 2025 Second SPA, we agreed to issue and sell, in a private placement transaction,
an aggregate of 3,300 shares of its newly created Series Y Convertible Preferred Stock, as defined below, with an aggregate stated value
of $3.3 million, and warrants to purchase up to 3,300,000 shares of the Company’s common stock, for aggregate gross proceeds of
$3.0 million. The Series Y Convertible Preferred Stock has a stated value of $1,000 and is convertible into Common Stock at an initial
conversion price of $2.00 per share (i.e., 1,650,000 shares of Common Stock), subject to adjustments. Accordingly, subject to receipt
of approval of the stockholders of the Company, the Investor will beneficially own the majority of the shares of common stock of the Company
and may have control over the Company. Therefore, if the stockholders’ approval is obtained, the Investor may cause the Company
to change its business, strategy and objectives. However, our ability to fully realize the benefits of the 2025 Second SPA, including
the issuance of shares in excess of the NYSE American 19.99% limitation, as described further below, is contingent upon obtaining the
stockholder approval required pursuant to the 2025 Second SPA. Failure to obtain this approval would severely limit our financial flexibility,
potentially requiring us to seek alternative financing on less favorable terms, or cease our operations, which would have a material adverse
effect on our business and financial condition.

Our Product Pipeline

We do not have any products approved or available
for sale, our product candidates are still in the clinical development stages, and we have not generated any revenue from product sales.

Ongoing Programs

BX011 - Treatment of Diabetic Foot Infections, or DFI

BX011 is a fixed multi-phage cocktail, for the
treatment of DFI associated with Staphylococcus aureus, or S. aureus, a key bacterium implicated in development and exacerbation of DFI.
DFI is a serious bacterial infection commonly arising from an ulcer on the foot and is a leading cause of amputation in patients with
diabetes. We previously reported positive statistically significant results targeting S. aureus in diabetic foot osteomyelitis, or
DFO, patients. BX011 incorporates multiple proprietary phages, among them phage previously evaluated in the BX211 study, to provide broad
and potent coverage against this S. aureus in DFI patients. BX011’s advancement will continue in alignment with ongoing discussions
with the U.S. Defense Health Agency and subject to the availability of necessary financial resources, with plans to initiate a Phase 2a
clinical trial in DFI.

BX211 – Treatment of Diabetic Foot Osteomyelitis (DFO)

BX211 is a phage therapy for the treatment of DFO
associated with S. aureus. The personalized phage treatment tailors a specific phage selected from a proprietary phage-bank according
to the specific strain of S. aureus biopsied and isolated from each patient. DFO is a bacterial infection of the bone that usually develops
from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. We believe that scientific literature demonstrating
the potential benefit in treating osteomyelitis using phage in animal models as well as numerous successful compassionate cases using
phage therapy to treat DFO patient support our approach of using phage therapy to treat DFO.

In March 2025, we announced positive results from
the phase 2 trial evaluating BX211 for the treatment of DFO, or the DFO Trial. The DFO Trial is a randomized, double-blind, placebo-controlled,
multi-center study investigating the safety, tolerability, and efficacy of BX211 to treat individuals with DFO associated with S. aureus.
The DFO Trial enrolled a total of 41 patients randomized for treatment at a 2:1 ratio, 26 of whom received intravenous, or IV, and topical
administration of BX211 on week 1 followed by a topical weekly dose through week 12, while 15 patients were assigned to the placebo arm.
Over the 12-week treatment period, all subjects (treatment and placebo) were also treated in accordance with standard of care, including
with systemic antibiotic therapy as appropriate. A readout of the DFO Trial results at week 13 evaluated healing of the wound associated
with osteomyelitis. The primary efficacy endpoint was percent area reduction, or PAR, of study ulcer through week 13. Study design was
guided in part by experience with numerous compassionate cases using phage therapy for the treatment of DFO and osteomyelitis.

Results from the DFO Trial findings included:

●BX211 was found to be safe and well-tolerated.

●BX211 produced sustained and statistically significant PAR
of ulcer size (p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo (standard of care) starting at week 7 and a
difference greater than 40% by week 10.

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●BX211 produced statistically significant improvements in both
ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline) (p=0.048), and in reducing the expansion of ulcer area
(p=0.017), compared to placebo.

●BX211 demonstrated favorable trends compared to placebo across
several additional clinical parameters, including: proportion of visits with no clinical evidence of infection; evidence of resolving
DFO by MRI/X-ray at week 12; proportion of patients with abnormal C-Reactive Protein, or CRP, at baseline that achieved a reduction of
CRP of at least 50% at any point in the study; and greater Wagner scale improvement. The Wagner Scale is a clinical grading system used
to classify the severity of diabetic foot ulcers, ranging from 0 (intact skin) to 5 (extensive gangrene).

●Through week 13, BX211 demonstrated comparable efficacy against
both Methicillin-susceptible and resistant strains, as well as against high and low biofilm producers—consistent with the orthogonal
mechanism of phage therapy to antibiotics and its inherent anti-biofilm capabilities.

All p-values described in the above DFO Trial are non-adjusted.

Given the straightforward pathway for regulatory approval
in DFI provided by the FDA, BiomX is prioritizing the development of BX011 for DFI before potential expansion to address DFO patient populations,
which share the same S. aureus bacterial target, pending sufficiency of financial resources.

National Institutes of Health, or NIH, study in Cystic Fibrosis,
or CF

We are supporting a study conducted by the NIH
and The Antibacterial Resistance Leadership Group targeting Pseudomonas aeruginosa, or P. Aeruginosa, infections in CF patients under
FDA emergency Investigational New Drug allowance. The Phase 1b/2, multi-centered, randomized, double-blind, placebo-controlled trial is
assessing the safety and microbiological activity of a single IV dose of bacteriophage therapy in cystic fibrosis subjects colonized with
P. aeruginosa.

Discontinued programs

BX004 – Treatment of Cystic Fibrosis

BX004 is our therapeutic phage product candidate
under development for chronic pulmonary infections caused by P. aeruginosa, a main contributor to morbidity and mortality in patients
with CF. Enhanced resistance to antibiotics develops, particularly in CF patients, due to extensive drug use consisting of prolonged and
repeated broad-spectrum antibiotic courses often beginning in childhood, and leading to the appearance of multidrug-resistant strains.
In preclinical in vitro studies, BX004 was shown to be active against antibiotic resistant strains of P. aeruginosa and demonstrated
the ability to penetrate biofilm, an assemblage of surface-associated microbial cells enclosed in an extracellular polymeric substance
and one of the leading causes for antibiotic resistance.

In August 2025, we announced that the FDA had placed
a clinical hold on the Company’s Phase 2b clinical trial of the BX004 product candidate, or the Study. As a result of the FDA’s
notification, patient screening and enrollment in the U.S. portion of the Study had been paused. Furthermore, in November 2025, we announced
that the FDA was continuing its evaluation of the third-party nebulizer device used in the Study in connection with the clinical hold,
and that an independent DMC recommended that the Study continue with an adjusted dosing regimen.

In light of the foregoing, and as detailed above,
in December, 2025, we discontinued the development of BX004, following internal analysis and DMC feedback, on an alternative dosing regimen
or treatment strategy which were beyond the Company’s available resources.

BX005 – Treatment of Atopic Dermatitis, or AD

BX005 is our topical phage product candidate targeting
S. aureus, a bacterium associated with the development and exacerbation of inflammation in AD. S. aureus is more abundant
on the skin of AD patients than on the skin of healthy individuals and on lesional skin than non-lesional skin. It also increases in abundance,
becoming the dominant bacteria, when patients experience flares. By reducing the load of S. aureus, BX005 is designed to shift the
skin microbiome composition to its ‘pre-flare’ state and potentially provide a clinical benefit. In preclinical in vitro
studies, BX005 was shown to eradicate over 90% of strains, including antibiotic resistant strains, from a panel of S. aureus strains (120
strains isolated from skin of subjects from the U.S. and Europe). On April 8, 2022, the FDA approved the Company’s Investigational
New Drug, or IND, application for BX005.In 2024, we discontinued the development of BX005.

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Our Strategy

Our goal is to develop multiple products based
on the ability of phage to precisely target harmful bacteria and on our ability to screen, identify and optimally combine different phage,
both naturally occurring and generated using synthetic engineering, to develop these treatments. We intend to continue to investigate
clinical safety and efficacy of our lead phage-based product candidates to treat DFI and DFO; however, our business, strategy, and objectives
are expected to be subject to change in accordance with the plans of the Investor, should they become a majority stockholder upon stockholder
approval.

Our phage discovery platform

Our approach is driven by the convergence of several
factors: a rapidly increasing understanding of phage, including the links between phage behaviors and their genomes; growing evidence
that the presence of specific harmful bacteria may impact chronic diseases, such as DFI, making them in principle, amenable to treatment
with phage; and by a growing number of anecdotal reports from different academic centers of successful compassionate use of phage to treat
seriously ill patients who were unresponsive to other therapies. We believe our phage therapeutic product candidates have the potential
to treat conditions and diseases by precisely targeting pathogenic bacteria without disrupting elements of the healthy microbiota. Our
phage-based product candidates, either fixed phage cocktails or personalized phage treatments, are developed utilizing our proprietary
research and development platforms.

We combine multiple technologies that originate
from the laboratories of our scientific founders and that were developed internally. Technologies that were developed by our scientific
founders are described in leading scientific journals. One of our scientific founders, Professor Rotem Sorek, a Professor in the Department
of Molecular Genetics at the Weizmann Institute of Science, or WIS, is a world leader in phage genomics and bacterial defense mechanisms.
The combination of the technologies and expertise from our scientific founders in each of their respective fields is critical in enabling
us to focus on treating complex human diseases and conditions by precise manipulation of the microbiome.

Additionally, we developed proprietary assays and
screening technology for robust and high throughput testing and patient specific targeting. The patient specific targeting platform combines
state of the art automation with advanced microbiology assays. We believe that the output is a reproducible conclusive decision for optimal
phage matching, based on multiple factors, including success of phage infection, suppression of resistant mutants, and antibiofilm activity.

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Intellectual Property

We strive to protect the proprietary technology
that we believe is important to our business, including seeking and maintaining patent protection in the United States and internationally
for our product candidates and discovery platform. We also rely on trademarks, trade secrets, know-how, copyrights, continuing technological
innovation and in-licensing opportunities to develop and maintain our proprietary position. For more information regarding the risks related
to our intellectual property, see “Risk Factors — Risks Related to our Licensed and Co-Owned Intellectual Property.”

We plan to continue to expand our intellectual
property estate by filing patent applications directed to formulations, related methods of treatment, methods of manufacture or identification
from our ongoing development of our product candidates, as well as discovery based on our proprietary product platform. Our success will
depend on our ability to obtain and maintain patent and other proprietary protection for commercially important technology, inventions
and know-how related to our business, defend, and enforce any patents that we may obtain, preserve the confidentiality of our trade secrets
and know-how and operate without infringing the valid and enforceable patents and proprietary rights of third parties.

Because patent applications in the United States
and certain other jurisdictions are maintained in secrecy for 18 months or potentially even longer, and because publication of discoveries
in the scientific or patent literature often lags behind actual discoveries and patent application filings, we cannot be certain of the
priority of inventions covered by pending patent applications. Accordingly, we may not have been the first to invent the subject matter
disclosed in some of our patent applications or the first to file patent applications covering such subject matter, and we may have to
participate in interference proceedings or derivation proceedings declared by the United States Patent and Trademark Office, or USPTO,
to determine priority of invention.

Patent portfolio

Our patent portfolio consists of one patent family
(United States, Canada, European Patent Office, China and Japan), solely owned by APT and directed to treating implantable device infections
among them staphylococcus aureus infections, common in patients with DFO. For some of the applications, prosecution has not started, and
others are in the early stages of prosecution in the United States and in selected jurisdictions outside of the United States. Prosecution
is a lengthy process, during which the scope of the claims initially submitted for examination by the USPTO is often significantly narrowed
by the time they issue, if they issue at all.

Patent term

The term of individual patents depends upon the
legal term of the patents in the countries in which they are obtained. In most countries in which we file patent applications, including
the United States, the base term is 20 years from the filing date of the earliest-filed non-provisional patent application from which
the patent claims priority. The term of a United States patent can be lengthened by patent term adjustment, which compensates the owner
of the patent for administrative delays at the USPTO. In some cases, the term of a United States patent is shortened by a terminal disclaimer
that reduces its term to that of an earlier-expiring patent. The term of a United States patent may be eligible for patent term extension
under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act, to account for at least
some of the time the drug is under development and regulatory review after the patent is granted. With regard to a drug for which FDA
approval is the first permitted marketing of the active ingredient, the Hatch-Waxman Act allows for extension of the term of one United
States patent that includes at least one claim covering the composition of matter of such an FDA-approved drug, an FDA-approved method
of treatment using the drug and/or a method of manufacturing the FDA-approved drug. The extended patent term cannot exceed the shorter
of five years beyond the non-extended expiration of the patent or fourteen years from the date of the FDA approval of the drug, and a
patent cannot be extended more than once or for more than a single product. During the period of extension, if granted, the scope of exclusivity
is limited to the approved product for approved uses. Some foreign jurisdictions, including Europe and Japan, have analogous patent term
extension provisions, which allow for extension of the term of a patent that covers a drug approved by the applicable foreign regulatory
agency.

In the future, if and when our product candidates
receive FDA approval, we expect to apply, if appropriate, for patent term extension on patents directed to those product candidates, their
methods of use and/or methods of manufacture. However, there is no guarantee that the applicable authorities, including the FDA in the
United States, will agree with our assessment of whether such extensions should be granted, and if granted, the length of such extensions.

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Trade Secrets and Know-How

In addition to patents, we rely on trade secrets
and know-how to develop and maintain our competitive position. We typically rely on trade secrets to protect aspects of our business that
are not amenable to, or that we do not consider appropriate for, patent protection. We protect trade secrets and know-how by establishing
confidentiality agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors and collaborators.
These agreements provide that all confidential information developed or made known during the course of an individual’s or entities’
relationship with us must be kept confidential during and after the relationship. These agreements also provide that all inventions resulting
from work performed for us or relating to our business and conceived or completed during the period of employment or assignment, as applicable,
shall be our exclusive property. In addition, we take other appropriate precautions, such as physical and technological security measures,
to guard against misappropriation of its proprietary information by third parties.

Although we take steps to protect our proprietary
information and trade secrets, including through contractual means with our employees and consultants, third parties may independently
develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our
technology. Thus, we may not be able to meaningfully protect our trade secrets and benefit from the exclusive use thereof. For more information
regarding the risks related to our intellectual property, see “Risk Factors — Risks Related to Our Licensed and Co-Owned
Intellectual Property.”

Competition

The biotechnology and pharmaceutical industries
are characterized by rapidly advancing technologies, strong competition and an emphasis on proprietary products. While we believe that
our technology, knowledge and experience provide us with competitive advantages, we face substantial competition from many different sources,
including larger pharmaceutical companies with more resources. Specialty biotechnology companies, academic research institutions, governmental
agencies, as well as public and private institutions are also potential sources of competitive products and technologies. We believe that
the key competitive factors affecting the success of any of our product candidates will include efficacy, safety profile, time to market,
cost, level of promotional activity and intellectual property protection.

We
are aware of a number of biotechnology companies developing bacteriophage products to treat diseases. To our knowledge, several biotechnology
companies, such as Locus Biosciences, Inc., Armata Pharmaceuticals, Inc. and SNIPR Biome, as well as academic institutions, have discovery
stage or clinical programs utilizing naturally occurring phage or synthetic biology approaches. In addition, with respect to DFI/DFO,
we are aware of several investigational and marketed products to treat the indications that we are targeting with our product candidates,
including, but not limited to, TP-102 being developed by Technophage, a phage-based product being developed by Phaxiam.

Many of our competitors, either alone or with their
strategic partners, have substantially greater financial, technical and human resources than ours and significantly greater experience
in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of products and the commercialization
of those products. Accordingly, our competitors may be more successful than us in discovering product candidates, obtaining approval for
such product candidates and achieving widespread market acceptance. Our competitors’ products may be more effective, or more effectively
marketed and sold, than any product we may commercialize and may render our product candidates obsolete or non-competitive before we can
recover the expenses of developing and commercializing any of our product candidates. We anticipate that we will face intense and increasing
competition as new drugs enter the market and advanced technologies become available.

These third parties compete with us in recruiting
and retaining qualified scientific, clinical, manufacturing, sales and marketing and management personnel, establishing clinical trial
sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our program.

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Sales and Marketing

We may consider to pursue the commercialization
of our drug product candidates either by building internal sales and marketing capabilities or through collaborations with others.

Government Regulation

Government authorities in the United States and
other countries regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging,
storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import
of drug and biological products. Generally, before a new drug or biologic can be studied in human clinical trials or marketed, considerable
data demonstrating its quality, safety, efficacy, purity, and/or potency must be obtained, organized into a format specific for each regulatory
authority, submitted for review and approved by the regulatory authority where the product is intended to be studied or marketed.

U.S. Biological Product Development Process

In the United States, the FDA regulates drugs under
the Federal Food, Drug, and Cosmetic Act, or the FDCA, and its implementing regulations under the FDCA, the Public Health Service Act,
or the PHSA, and their implementing regulations. Both drugs and biologics are also subject to other federal, state and local statutes
and regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state and local
statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with applicable U.S.
requirements at any time during the product development, approval, or post-marketing process may subject an applicant to administrative
or judicial sanctions. These sanctions could include, among other actions, the FDA’s refusal to approve pending applications, withdrawal
of an approval or license revocation, a clinical hold, untitled or warning letters, product recalls or market withdrawals, product seizures,
total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement
and civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.

Certain of our current product candidates and future
product candidates must be approved by the FDA through a Biologics License Application, or BLA, process before they may be legally marketed
in the United States. The process generally involves the following. However, the Trump administration may change or overhaul existing
drug regulations, which would lead to additional time and money to comply with:

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Completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with GLP requirements, if needed;

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Submission to the FDA of an IND, which must become effective before human clinical trials may begin;

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Approval by an institutional review board, or IRB, at each clinical trial site before each trial may be initiated;

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Performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practice, or GCP, requirements and other clinical trial-related regulations to establish the safety, purity, potency and efficacy of the investigational product for each proposed indication;

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Submission to the FDA of a BLA;

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A determination by the FDA within 60 days of its receipt of a BLA to accept the application for review;

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Satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the biologic will be produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength, quality and purity;

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Potential FDA audit of the clinical trial sites that generated the data in support of the BLA;

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Payment of user fees for FDA review of the BLA (unless a fee waiver applies); and

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FDA review and approval of the BLA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the biologic in the United States.

Preclinical Studies and IND

Preclinical studies include laboratory evaluation
of product chemistry and formulation, as well as in vitro and animal studies to establish a rationale for therapeutic use and in
some cases to assess the potential for adverse events. The conduct of preclinical studies is subject to federal regulations and requirements,
including in some cases GLP regulations for safety/toxicology studies. An IND sponsor must submit the results of the preclinical tests,
together with manufacturing information, analytical data, any available clinical data or literature and plans for clinical trials, among
other things, to the FDA as part of an IND. An IND is a request for authorization from the FDA to administer an investigational product
to humans, and, must become effective before human clinical trials may begin. Some long-term preclinical testing may continue after the
IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time, the FDA raises
concerns or questions related to one or more proposed clinical trials and places the trial on clinical hold. In such a case, the IND sponsor
and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result
in the FDA allowing clinical trials to commence.

Clinical Trials

Clinical trials involve the administration of the
drug or biological product candidate to healthy volunteers or disease-affected patients under the supervision of qualified investigators,
generally physicians not employed by, or under, the trial sponsor’s control. Clinical trials are conducted under protocols detailing,
among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters
to be used to monitor subject safety and efficacy, including stopping rules that assure a clinical trial will be stopped if certain adverse
events should occur. Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND. Clinical trials
must be conducted and monitored in accordance with the FDA’s regulations comprising the GCP requirements, including the requirement
that all research subjects provide informed consent. Further, each clinical trial must be reviewed and approved by an IRB at or servicing
each institution at which the clinical trial will be conducted. An IRB is charged with protecting the welfare and rights of study participants
and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in
relation to anticipated benefits. The IRB also approves the form and content of the informed consent that must be signed by each clinical
trial subject or his or her legal representative and must monitor the clinical trial until completed. There are also requirements governing
the reporting of ongoing clinical trials and completed clinical trial results to public registries. Information about certain clinical
trials, including clinical trial results, must be submitted within specific timeframes for publication on the www.clinicaltrials.gov website.

Clinical trials generally are conducted in three
sequential phases, known as Phase 1, Phase 2 and Phase 3, and may overlap.

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Phase 1 clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism, pharmacologic action, side effect tolerability and safety of the product candidate.

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Phase 2 clinical trials generally involve studies in disease-affected patients to evaluate proof of concept and/or determine the dosing regimen(s) for subsequent investigations. At the same time, safety and sometimes further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified and a preliminary evaluation of efficacy is conducted.

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Phase 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide an adequate basis for labeling for new drugs.

Post-approval trials, sometimes referred to as
Phase 4 clinical trials, may be conducted after initial marketing approval. These trials are conducted to gain additional experience from
the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance of Phase 4
clinical trials as a condition of approval of a BLA.

Progress reports detailing the results of the clinical
trials, among other information, must be submitted at least annually to the FDA and written IND safety reports must be submitted to the
FDA and the investigators for serious and unexpected suspected adverse events, findings from other studies or animal or in vitro testing
that suggest a significant risk for human subjects and any clinically important increase in the rate of a serious suspected adverse reaction
over that listed in the protocol or investigator brochure.

It is possible for Phase 1, Phase 2, Phase 3 and
other types of clinical trials not to be completed successfully within a specified period, if at all. The FDA or the sponsor may suspend
or terminate a clinical trial at any time on various grounds, including a finding that the patients are being exposed to an unacceptable
health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being
conducted in accordance with the IRB’s requirements or if the tested biological product has been associated with unexpected serious
harm to patients. Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical
trial sponsor, or the Data Safety Monitoring Board. This group provides authorization for whether a trial may move forward at designated
check points based on access to certain data from the trial.

Concurrent with clinical trials, companies may
need to complete additional animal studies and also must develop additional information about the chemistry and physical characteristics
of the biologic as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
The manufacturing process must be capable of consistently producing quality batches of the product and, among other things, companies
must develop methods for testing the identity, strength, quality and purity of the final product. Additionally, appropriate packaging
must be selected and tested, and stability studies must be conducted to demonstrate that the product candidates do not undergo unacceptable
deterioration over their shelf life.

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FDA Review Process

Following completion of the clinical trials, data
are analyzed to assess whether the investigational product is safe and effective for the proposed indicated use or uses and also meets
the regulatory requirements for potency and purity. The results of preclinical studies and clinical trials are then submitted to the FDA
as part of a BLA, along with proposed labeling, chemistry and manufacturing information to ensure product quality and other relevant data.
The BLA is a request for approval to market the biological product for one or more specified indications and must contain proof of safety,
purity and potency. The application may include both negative and ambiguous results of preclinical studies and clinical trials, as well
as positive findings. Data may come from company-sponsored clinical trials intended to test the safety and efficacy of a product’s
use or from a number of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted
must be sufficient in quality and quantity to establish the safety and efficacy in the intended indication, purity and potency of the
investigational product to the satisfaction of the FDA. FDA approval of a BLA must be obtained before a biologic may be marketed in the
United States. Under the Prescription Drug User Fee Act, or PDUFA, as amended, each BLA must be accompanied by a user fee. The FDA adjusts
the PDUFA user fees on an annual basis. Fee waivers or reductions are available in certain circumstances, including a waiver of the application
fee for the first application filed by a small business.

The FDA reviews all submitted BLAs before it accepts
them for filing and may request additional information rather than accept the BLA for filing. The FDA must make a decision on accepting
a BLA for filing within 60 days of receipt, and such a decision could include a refusal to file by the FDA. Once the submission is accepted
for filing, the FDA begins an in-depth review of the BLA. Under the goals and policies agreed to by the FDA under PDUFA, the FDA has 10
months, from the filing date, in which to complete its initial review of an original BLA and respond to the applicant, and 6 months from
the filing date of an original BLA designated for priority review. The FDA does not always meet its PDUFA goal dates for standard and
priority BLAs, and the review process is often extended by FDA requests for additional information or clarification.

Before approving a BLA, the FDA will conduct a
pre-approval inspection of the manufacturing facilities for the new product to determine whether they comply with cGMP requirements. The
FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements
and adequate to assure consistent production of the product within required specifications. The FDA also may audit data from clinical
trials to ensure compliance with GCP requirements. Additionally, the FDA may refer applications for novel products or products which present
difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for
review, evaluation and a recommendation as to whether the application should be approved and under what conditions, if any. The FDA is
not bound by recommendations of an advisory committee, but it considers such recommendations when making decisions on approval. The FDA
likely will reanalyze the clinical trial data, which could result in extensive discussions between the FDA and the applicant during the
review process.

After the FDA evaluates a BLA, it will issue an
approval letter, or a Complete Response Letter. An approval letter authorizes commercial marketing of the biologic with specific prescribing
information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete and the
application will not be approved in its present form. A Complete Response Letter usually describes all the specific deficiencies in the
BLA identified by the FDA. The Complete Response Letter may require additional clinical data and/or other significant and time-consuming
requirements related to clinical trials, preclinical studies or manufacturing. If a Complete Response Letter is issued, the applicant
may either resubmit the BLA, addressing all the deficiencies identified in the letter, or withdraw the application. Even if such data
and information are submitted, the FDA may decide that the BLA does not satisfy the criteria for approval. Data obtained from clinical
trials are not always conclusive and the FDA may interpret data differently than the sponsor’s interpretation of the same data.

10

Pediatric Information

Under the Pediatric Research Equity Act of 2003,
or PREA, a BLA or supplement to a BLA must contain data to assess the safety and efficacy of the biologic for the claimed indications
in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product
is safe and effective. The FDA may grant deferrals for submission of pediatric data or full or partial waivers. A sponsor who is planning
to submit a marketing application for a drug that includes a new active ingredient, new indication, new dosage form, new dosing regimen
or new route of administration must submit an initial Pediatric Study Plan, or PSP, within 60 days of an end-of-Phase 2 meeting or,
if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 study. The initial PSP must include
an outline of the pediatric study or studies that the sponsor plans to conduct, including study objectives and design, age groups, relevant
endpoints and statistical approach, or a justification for not including such detailed information, and any request for a deferral of
pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric studies along with supporting information.
The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time
if changes to the pediatric plan need to be considered based on data collected from preclinical studies, early phase clinical trials and/or
other clinical development programs.

Post-marketing Requirements

Following approval of a new product, the manufacturer
and the approved product are subject to continuing regulation by the FDA, including, among other things, monitoring and record-keeping
activities, reporting of adverse experiences, complying with promotion and advertising requirements, which include restrictions on promoting
products for unapproved uses or patient populations (known as “off-label use”) and limitations on industry-sponsored scientific
and educational activities. Although physicians may prescribe legally available products for off-label uses, manufacturers may not market
or promote such uses. Prescription drug and biologic promotional materials must be submitted to the FDA in conjunction with their first
use. Further, if there are any modifications to the biologic, including changes in indications, labeling or manufacturing processes or
facilities, the applicant may be required to submit and obtain FDA approval of a new BLA or BLA supplement, which may require the development
of additional data or preclinical studies and clinical trials.

The FDA may also place other conditions on approvals
including the requirement for a Risk Evaluation and Mitigation Strategy, or REMS, to assure the safe use of the product. If the FDA concludes
a REMS is needed, the sponsor of the BLA must submit a proposed REMS. The FDA will not approve the BLA without an approved REMS, if required.
A REMS could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution
methods, patient registries and other risk minimization tools. Any of these limitations on approval or marketing could restrict the commercial
promotion, distribution, prescription or dispensing of products. Newly discovered or developed safety or effectiveness data may require
changes to a product’s approved labeling, including the addition of new warnings and contraindications, and also may require the
implementation of other risk management measures, including a REMS or the conduct of post-marketing studies to assess a newly discovered
safety issue. Product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following initial marketing.

FDA regulations require that products be manufactured
in specific approved facilities and in accordance with cGMP regulations, which require, among other things, quality control and quality
assurance, the maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP. Manufacturers
and other entities involved in the manufacture and distribution of approved drugs or biologics are required to register their establishments
with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for
compliance with cGMP requirements and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area
of production and quality control to maintain cGMP compliance. The discovery of violative conditions, including failure to conform to
cGMP regulations, could result in enforcement actions, and the discovery of problems with a product after approval may result in restrictions
on a product, manufacturer or holder of an approved BLA, including recall.

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Biosimilars and Exclusivity

An abbreviated approval pathway for biological
products shown to be biosimilar to, or interchangeable with, an FDA licensed reference biological product was created by the Biologics
Price Competition and Innovation Act of 2009. This amendment to the PHSA, in part, attempts to minimize duplicative testing. Biosimilarity,
which requires that the biological product be highly similar to the reference product notwithstanding minor differences in clinically
inactive components and that there be no clinically meaningful differences between the product and the reference product in terms of safety,
purity and potency, can be shown through analytical studies, animal studies and a clinical trial or trials.

Interchangeability requires that a biological product
be biosimilar to the reference product and that the product can be expected to produce the same clinical results as the reference product
in any given patient and, for products administered multiple times to an individual, that the product and the reference product may be
alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative
to exclusive use of the reference biological product without such alternation or switch.

A reference biological product is granted 12 years
of data exclusivity from the time of first licensure of the product, and the FDA will not accept an application for a biosimilar or interchangeable
product based on the reference biological product until four years after the date of first licensure of the reference product. “First
licensure” typically means the initial date the particular product at issue was licensed in the United States. Date of first licensure
does not include the date of licensure of (and a new period of exclusivity is not available for) a biological product if the licensure
is for a supplement for the biological product or for a subsequent application by the same sponsor or manufacturer of the biological product
(or licensor, predecessor in interest, or other related entity) for a change (not including a modification to the structure of the biological
product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or
strength, or for a modification to the structure of the biological product that does not result in a change in safety, purity, or potency.

Pediatric exclusivity is another type of regulatory
market exclusivity in the United States, available under the Best Pharmaceuticals for Children Act by way of its application to biologics
through the Biologics Price Competition and Innovation Act. Pediatric exclusivity, if granted, adds six months to existing regulatory
exclusivity periods, which must be in place in order for pediatric exclusivity to apply. This six-month exclusivity may be granted based
on the voluntary completion of a pediatric trial in accordance with an FDA issued “Written Request” for such a trial, although
FDA may issue such a Written Request at the request of the sponsor.

Companion Diagnostics

We may employ companion diagnostics to identify
the most suitable phage to treat a specific patient under our personalized phage treatments and to help more accurately identify patients
sensitive to our phage cocktails, during our clinical trials and potentially also in connection with the commercialization of our product
candidates that we are developing or may in the future develop. Companion diagnostics can identify patients who are most likely to benefit
from a particular therapeutic product; identify patients likely to be at increased risk for serious side effects as a result of treatment
with a particular therapeutic product; or monitor response to treatment with a particular therapeutic product for the purpose of adjusting
treatment to achieve improved safety or effectiveness. Companion diagnostics are regulated as medical devices by the FDA and, as such,
require either clearance or approval prior to commercialization. The level of risk combined with available controls to mitigate risk determines
whether a companion diagnostic device requires Premarket Approval Application approval or is cleared through the 510(k) premarket notification
process. For a novel therapeutic product for which a companion diagnostic device is essential for the safe and effective use of the product,
the companion diagnostic device should be developed and approved or 510(k)-cleared contemporaneously with the therapeutic. The use of
the companion diagnostic device will be stipulated in the labeling of the therapeutic product.

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Government Regulation Outside of the United States

In addition to regulations in the United States,
we will be subject to a variety of regulations in other jurisdictions governing, among other things, clinical trials of drug products
as well as the approval, manufacture and distribution of our product candidates. Because biologically sourced raw materials are subject
to unique contamination risks, their use may be restricted in some countries. Whether or not we obtain FDA approval for a product candidate,
we must obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical trials or
marketing of the product in those countries. If we fail to comply with applicable foreign regulatory requirements, we may be subject to,
among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions
and criminal prosecution.

Clinical Trials

Certain countries outside of the United States
have a regulatory process similar to the U.S process that requires the submission of a clinical trial application much like the IND prior
to the commencement of human clinical trials. In the European Union, for example, a clinical trial application, or CTA, must be submitted
for each clinical trial in a centralized manner to the relevant national health authority and an independent ethics committee in each
country in which the trial is to be conducted through a single EU portal for harmonized assessment, much like the FDA and an IRB, respectively.
CTAs must be accompanied by an investigational medicinal product dossier with supporting information prescribed by the Clinical Trials
Regulation (and corresponding national laws of the member states) and further detailed in applicable guidance documents. Once the CTA
is approved in accordance with the European Commission and each country’s requirements, the clinical trial may proceed. A similar
process to the one described for the European Union is required in Israel for initiation of clinical trials. The requirements and process
governing the conduct of clinical trials vary from country to country. In all cases, the clinical trials must be conducted in accordance
with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.

Approval Process

In order to market our products, we must obtain
a marketing approval for each product and comply with numerous and varying regulatory requirements. The approval procedure varies among
countries and can involve additional testing in comparison to the testing carried out for the U.S. approval. The time required to obtain
approval in foreign countries may differ substantially from that required to obtain FDA approval. Clinical trials conducted in one country
may not be accepted by regulatory authorities in other countries. The regulatory approval process outside the United States generally
is subject to all of the same risks associated with obtaining FDA approval. In addition, in many countries outside the United States,
it is required that the product be approved for reimbursement before the product can be approved for sale in that country.

To obtain marketing approval of a medicinal product
under the European Union regulatory system, an applicant must submit a marketing authorization application, or MAA, under either a centralized
or a decentralized procedure. The decentralized procedure is based on a collaboration among the member states selected by the applicant.
In essence, the applicant chooses a ‘lead’ member state that will carry out the scientific assessment of the MAA and review
the product information. The other member states must recognize the outcome of such assessment and review except in case of a “serious
potential risk to public health.” The decentralized procedure results in the grant of a national marketing authorization in each
selected country. That procedure is available for all medicinal products unless they fall into the mandatory scope of the centralized
procedure. In practice, it is used for OTC, not highly innovative products, generic products and, increasingly, for biosimilars.

The centralized procedure provides for the grant
of a single marketing authorization by the European Commission that is valid for all European Union member states. The centralized procedure
is compulsory for certain medicinal products, including for medicinal products produced by certain biotechnological processes, advanced
therapy medicinal products, or ATMPs, and products with a new active substance and indicated for the treatment of certain diseases. For
products with a new active substance and indicated for the treatment of other diseases, products that are highly innovative or for which
a centralized process is in the interest of patients, the centralized procedure is optional.

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Under the centralized procedure, the CHMP, the
main scientific committee established at the European Medicines Agency, or EMA, is responsible for conducting the scientific assessment
of the future medicinal product. The CHMP is also responsible for several post-authorization and maintenance activities, such as the assessment
of modifications or extensions to an existing marketing authorization. The maximum timeframe for the evaluation of an MAA is 210 days,
excluding clock stops. The European Commission grants or refuses the marketing authorization, following a procedure that involves representatives
of the member states. The European Commission’s decision is in accordance with the CHMP scientific assessment except in very rare
cases.

Pursuant to Regulation (EC) 1394/2007, specific
rules apply to ATMPs, a category that is comprised of gene therapy medical products, somatic cell therapy medicinal products, and tissue-engineered
medicinal products. Those rules have triggered the adoption of guidelines on manufacturing, clinical trials and pharmacovigilance that
adapt the general regulatory requirements to the specific characteristics of ATMPs. Regulation (EC) 1394/2007 introduced a “hospital
exemption”, which authorizes hospitals to develop ATMP for their internal use without having obtained a marketing authorization
and to complying with European Union pharmaceutical law. The hospital exemption, which is in essence a compounded ATMP, has been transposed
in all Member States, sometimes in such a way that the ATMPs under the hospital exemption are competitive alternatives to ATMPs with marketing
authorization. The broad use of the hospital exemption by national hospitals led the European Commission to discuss with the Member States
a more reasonable application of the hospital exemption that would not undermine the common legal regime for ATMP.

Marketing authorization is valid for five years
in principle and the marketing authorization may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance
by the EMA or the competent authority of the authorizing member state. To this end, the marketing authorization holder must provide the
EMA or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations
introduced since the marketing authorization was granted, at least six months before the marketing authorization ceases to be valid. Once
renewed, the marketing authorization is valid for an unlimited period, unless the European Commission or the national competent authority
decides, on justified grounds relating to pharmacovigilance, to proceed with one additional renewal. Any authorization which is not followed
by the actual placing of the medicinal product on the European Union market (in case of centralized procedure) or on the market of the
authorizing member state within three years after authorization ceases to be valid (the so-called sunset clause).

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Expedited Development and Approval

Mechanisms are in place in many jurisdictions that
allow an earlier approval of the drug so that it reaches patients with unmet medical needs earlier. The European Union, for example, has
instituted several expedited approval mechanisms including two mechanisms that are specific to the centralized procedure:

●
the accelerated approval: the EMA may reduce the maximum timeframe for the evaluation of an MAA from 210 days to 150 days when the future medicinal product is of major interest from the point of view of public health, in particular from the viewpoint of therapeutic innovation.

●
the conditional marketing authorization: as part of its marketing authorization process, the European Commission may grant marketing authorizations on the basis of less complete data than is normally required.

A conditional marketing authorization may be granted
when the CHMP finds that, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not
been supplied, all the following requirements are met:

●
the risk/benefit balance of the medicinal product is positive;

●
it is likely that the applicant will be in a position to provide the comprehensive clinical data;

●
unmet medical needs will be addressed; and

●
the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data is still required.

The granting of a conditional marketing authorization
is typically restricted to situations in which only the clinical part of the application is not yet fully complete. Incomplete preclinical
or quality data may however be accepted if duly justified and only in the case of a product intended to be used in emergency situations
in response to public health threats.

Conditional marketing authorizations are valid
for one year, on a renewable basis. The conditions to which approval is subject will typically require the holder to complete ongoing
trials or to conduct new trials with a view to confirming that the benefit-risk balance is positive and to collect pharmacovigilance data.
Once the conditions to which the marketing authorization is subject are fulfilled, the conditional marketing authorization is transformed
into a regular marketing authorization. If, however, the conditions are not fulfilled with the timeframe set by EMA, the conditional marketing
authorization ceases to be renewed.

The EMA has also implemented the so-called “PRIME”
(PRIority MEdicines) status in order support the development and accelerate the approval of complex innovative medicinal products addressing
an unmet medical need. PRIME status enables early dialogue with the relevant EMA scientific committees and, possibly, some payors and
thus reinforces the EMA’s scientific and regulatory support. It also opens accelerated assessment of the MAA as PRIME status, is
normally reserved for medicinal products that may benefit from accelerated assessment, i.e., medicines of major interest from a public
health perspective, in particular from a therapeutic innovation perspective.

Finally, all medicinal products (i.e. decentralized
and centralized procedures) may benefit from an MA “under exceptional circumstances.” This marketing authorization is close
to the conditional marketing authorization as it is reserved to medicinal products to be approved for severe diseases or unmet medical
needs and the applicant does not hold the complete data set legally required for the grant of a marketing authorization. However, unlike
the conditional marketing authorization, the applicant does not have to provide the missing data and will never have to. The risk-benefit
of the medicinal product is reviewed annually. As a result, although the MA “under exceptional circumstances” is granted definitively,
the risk-benefit balance of the medicinal product is reviewed annually and the marketing authorization is withdrawn in case the risk-benefit
ratio is no longer favorable.

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Pediatrics

Mandatory testing in the pediatric population is
required in more and more jurisdictions. The European Union has enacted a complex and very stringent system that has inspired other jurisdictions,
including the United States and Switzerland. Any application for approval of (i) a medicinal product containing a new active substance
or (ii) a new therapeutic indication, pharmaceutical form or route of administration of an already authorized medicinal product which
contains an active substance still protected by a supplementary protection certificate, or SPC, or a patent that qualifies for an SPC,
must include pediatric data. Otherwise, the application is not validated by the competent regulatory authority. The submission of pediatric
data is mandatory in those cases, even if the application concerns an adult use. Submission of pediatric data is not required or fully
required if the EMA granted, respectively, a full or partial waiver to pediatric development. Moreover, that submission can be postponed
if the EMA grants a deferral in order not to delay the submission of the MAA for the adult population.

The pediatric data are generated through the implementation
of a pediatric investigation plan, or PIP, that is proposed by the company after completion of the PK studies in adults and agreed upon
by the EMA, typically after some modifications. The PIP lists all the studies to conduct and measures to take in order to prove the safety
and efficacy of the future medicinal product when used in children. The EMA may agree to modify the PIP at the company’s request.
The scope of the PIP is the adult therapeutic indication or the condition of which the adult application is part or even the mechanism
of action of the active substance, at the EMA’s quasi-discretion. This very broad discretion enables the EMA to require companies
to develop children indications that are different from the adult indications.

Completion of a PIP renders the company eligible
for a pediatric reward, which can be six-month extension of the term of the SPC. The reward is subject, among other conditions, to the
PIP being fully completed, to the pediatric medicinal product being approved in all the member states, and to the results of the pediatric
studies being mentioned, in one way or another (for example, the approval of a pediatric indication), in the summary of product characteristics
of the product.

Post-Marketing Requirements

Many countries impose post-marketing requirements
similar to those imposed in the United States, in particular safety monitoring or pharmacovigilance. In the European Union, pharmacovigilance
data are the basis for the competent regulatory authorities imposing the conduct of post-approval safety or efficacy study, including
on off-label use. Non-compliance with those requirements can result in significant financial penalties as well as the suspension or withdrawal
of the marketing authorization.

Supplementary Protection Certificate and Regulatory Exclusivities

In some countries other than the United States,
some of our patents may be eligible for limited patent term extension, depending upon the timing, duration and specifics of the regulatory
approval of our product candidates and any future product candidates. Furthermore, authorized drugs and biologics may benefit from regulatory
exclusivities (in additional to patent protection resulting from patents).

In the European Union, Regulation (EC) 469/2009
institutes SPCs. An SPC is an extension of the term of a patent that compensates for the patent protection lost because of the legal requirements
to conduct safety and efficacy tests and to obtain a marketing authorization before placing a medicinal product on the market. An SPC
may be applied for any active substance that is protected by a “basic patent” (a patent chosen by the patent holder, which
can be a product, process or application patent) and has not been placed on the market as a medicinal product before having obtained a
marketing authorization in accordance with European Union pharmaceutical law. The term of the SPC is maximum five years, and the combined
patent and SPC protection may not exceed fifteen years from the date of the first marketing authorization in the EEA. SPC rights are restricted
by both the basic patent and the marketing authorization, i.e., the SPC grants the same rights as those conferred by the basic patent
but limited to the active substance covered by the marketing authorization (and any use as medicinal product approved afterwards).

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While SPC are regulated at the European level,
they are granted by the national patent offices. The grant of an SPC requires a basic patent granted by the national patent office and
a marketing authorization, which is the first marketing authorization for the active substance as a medicinal product in the country.
Furthermore, no SPC must have already been granted to the active substance, and the application for the SPC must be filed with the national
patent office within six months of the first marketing authorization in the EEA or the grant of the basic patent, whichever is the latest.

In the future, we may apply for an SPC for one
or more of our currently owned or licensed European patents to add patent life beyond their current expiration date, depending on the
expected length of the clinical trials and other factors involved in the filing of the relevant MAA.

Furthermore, in the European Union, medicinal products
may benefit from the following regulatory exclusivities: data exclusivity, market protection, market exclusivity, and pediatric reward.

A medicinal product that contains a new active
substance (reference medicinal product) is granted eight years of data exclusivity followed by two years of market protection. Data exclusivity
prevents other companies from referring to the non-clinical and clinical data in marketing authorization dossier of the reference medicinal
product for submission of generic MAA purposes, and market protection prevents other companies from placing generics on the market. Pursuant
to the concept of global marketing authorization, any further development of that medicinal product (e.g., new indication, new form, change
to the active substance) by the marketing authorization holder does not trigger any new or additional protection. The authorization of
any new development is considered as “falling” into the initial marketing authorization with regard to regulatory protection;
hence, the new development only benefits from the regulatory protection that remains when it is authorized. The only exception is a new
therapeutic indication that is considered as bringing a significant clinical benefit in comparison to the existing therapies. Such new
indication will add one-year of market protection to the global marketing authorization, provided that it is authorized within the first
eight years of authorization (i.e., during the data exclusivity period). Moreover, a new therapeutic indication of a “well-established
substance” benefits from one-year data exclusivity but limited to the non-clinical and clinical data supporting the new indication.
Any active substance approved for at least ten years in the EEA qualifies as well-established substance.

Biosimilars may be approved through an abbreviated
approval pathway after the expiration of the eight-year data exclusivity period and may be marketed after the 10 or 11-year market protection
period. The approval of biosimilars requires the applicant to demonstrate similarity between the biosimilar and the biological medicinal
product and to submit the non-clinical and clinical data defined by the EMA. The biosimilar legal regime has been mainly developed through
EMA’s scientific guidelines applicable to categories of biological active substances. Unlike in the United States, interchangeability
is regulated by each member state.

Market exclusivity is a regulatory protection exclusively
afforded to new medicinal products that precludes the EMA or a national regulatory authority from validating another MAA, and the European
Commission or a national regulatory authority from granting another marketing authorization, for a same or similar medicinal product and
a same therapeutic indication, for a period of ten years from approval (see above).

Pediatric reward is another regulatory exclusivity.
Completion of a PIP renders the company eligible for a pediatric reward, which can be six-month extension of the term of the SPC. In case
a PIP is completed on a voluntary basis, i.e., for an approved medicinal product that is not or no longer protected by an SPC or a basic
patent, the pediatric reward takes the form of a “pediatric use marketing authorization”, or PUMA. That special authorization
does not fall into the global marketing authorization and thus benefits from eight years of data exclusivity followed by two or three
years of market protection.

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Other U.S. Healthcare Laws and Compliance Requirements

In addition to FDA restrictions on the marketing
of pharmaceutical products, we may be subject to various federal and state laws targeting fraud and abuse in the healthcare industry.
These laws may impact, among other things, our business or financial arrangements and relationships through which we market, sell and
distribute the products, if any, for which we obtain approval. The laws that may affect our ability to operate include:

●
the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs; a person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act, or FCA, or federal civil money penalties statute;

●
federal civil and criminal false claims laws and civil monetary penalties laws, such as the FCA, which impose criminal and civil penalties and authorize civil whistleblower or qui tam actions, against individuals or entities for, among other things: knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent; making, using or causing to be made or used, a false statement or record material to a false or fraudulent claim or obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government;

●
the civil monetary penalties law, which prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of items or services reimbursable by a federal or state governmental program;

●
the Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

●
the federal transparency requirements under the Affordable Care Act, or ACA, including the provision commonly referred to as the Physician Payments Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the U.S. Department of Health and Human Services information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members;

●
federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs; and

●
federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.

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Additionally, we are subject to state and foreign
equivalents of each of the healthcare laws described above, among others, some of which may be broader in scope and may apply regardless
of the payor. Many U.S. states have adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of
patients for healthcare services reimbursed by any source, not just governmental payors, including private insurers. In addition, some
states have passed laws that require pharmaceutical companies to comply with the April 2003 Office of Inspector General Compliance Program
Guidance for Pharmaceutical Manufacturers and/or the Pharmaceutical Research and Manufacturers of America’s Code on Interactions
with Healthcare Professionals. Several states also impose other marketing restrictions or require pharmaceutical companies to make marketing
or price disclosures to the state. There are ambiguities as to what is required to comply with these state requirements and if we fail
to comply with an applicable state law requirement we could be subject to penalties. Finally, there are state and foreign laws governing
the privacy and security of health information, many of which differ from each other in significant ways and often are not pre-empted
by HIPAA, thus complicating compliance efforts.

Because of the breadth of these laws and the narrowness
of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge
under one or more of such laws.

Violations of fraud and abuse laws may be punishable
by criminal and/or civil sanctions, including penalties, fines, imprisonment and/or exclusion or suspension from federal and state healthcare
programs such as Medicare and Medicaid and debarment from contracting with the U.S. government. In addition, private individuals have
the ability to bring actions on behalf of the U.S. government under the federal FCA, as well as under the false claims laws of several
states.

Law enforcement authorities are increasingly focused
on enforcing fraud and abuse laws, and it is possible that some of our practices may be challenged under these laws. Efforts to ensure
that our current and future business arrangements with third parties, and our business generally, will comply with applicable healthcare
laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices,
including our arrangements with physicians and other healthcare providers, some of whom receive stock options as compensation for services
provided, may not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse
or other healthcare laws and regulations. If any such actions are instituted against us, and we are not successful in defending ourselves
or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and
administrative penalties, damages, disgorgement, monetary fines, imprisonment, possible exclusion from participation in Medicare, Medicaid
and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment
of our operations, any of which could adversely affect our ability to operate our business and our results of operations. In addition,
the approval and commercialization of any of our product candidates outside the United States will also likely subject us to foreign equivalents
of the healthcare laws mentioned above, among other foreign laws.

If any of the physicians or other healthcare providers
or entities with whom we expect to do business are found to be not in compliance with applicable laws, they may be subject to criminal,
civil or administrative sanctions, including exclusions from government funded healthcare programs, which may also adversely affect our
business.

Much like the federal Anti-Kickback Statute in
the United States, the provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement,
purchase, supply, order or use of medicinal products is also prohibited in the European Union. The provision of benefits or advantages
to physicians is mainly governed by the national anti-bribery laws of the member states, such as the UK Bribery Act 2010, or national
anti-kickback provisions (France, Belgium, etc.). Infringement of these laws could result in substantial fines and imprisonment. In certain
member states, payments made to physicians must be publicly disclosed. Moreover, agreements with physicians often must be the subject
of prior notification and approval by the physician’s employer, his or her competent professional organization and/or the regulatory
authorities of the individual member states. These requirements are provided in the national laws, industry codes or professional codes
of conduct, applicable in the member states. Failure to comply with these requirements could result in reputational risk, public reprimands,
administrative penalties, fines or imprisonment.

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Additional Regulation

In addition to the foregoing, state and federal
laws regarding environmental protection and hazardous substances, including the Occupational Safety and Health Act, the Resource Conservancy
and Recovery Act and the Toxic Substances Control Act, affect our business. These and other laws govern our use, handling and disposal
of various biological, chemical and radioactive substances used in, and wastes generated by, our operations. If our operations result
in contamination of the environment or expose individuals to hazardous substances, we could be liable for damages and governmental fines.
We believe that we are in material compliance with applicable environmental laws and that continued compliance therewith will not have
a material adverse effect on our business. We cannot predict, however, how changes in these laws may affect our future operations.

U.S. Foreign Corrupt Practices Act

The U.S. Foreign Corrupt Practices Act, to which
we are subject, prohibits corporations and individuals from engaging in certain activities to obtain or retain business or to influence
a person working in an official capacity. It is illegal to pay, offer to pay or authorize the payment of anything of value to any foreign
government official, government staff member, political party or political candidate in an attempt to obtain or retain business or to
otherwise influence a person working in an official capacity. Similar rules apply to many other countries worldwide such as France (“Loi
Sapin”) or the United Kingdom (UK Bribery Act).

U.S. Healthcare Reform

A primary trend in the U.S. healthcare industry
and elsewhere is cost containment. Government authorities and other third-party payors have attempted to control costs by limiting coverage
and the amount of reimbursement for particular medical products. For example, in March 2010, the ACA was enacted, which, among other things,
increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; introduced a new methodology
by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled,
implanted or injected; extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled in Medicaid managed
care plans; imposed mandatory discounts for certain Medicare Part D beneficiaries as a condition for manufacturers’ outpatient drugs
coverage under Medicare Part D; subjected drug manufacturers to new annual fees based on pharmaceutical companies’ share of sales
to federal healthcare programs; created a new Patient Centered Outcomes Research Institute to oversee, identify priorities in and conduct
comparative clinical effectiveness research, along with funding for such research; and established the Center for Medicare & Medicaid
Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending.

Since its enactment, there have been a number of
significant changes to the ACA. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA
without specifically ruling on the constitutionality of the ACA. Prior to the U.S. Supreme Court’s decision, President Biden issued
an executive order initiating a special enrollment period from February 15, 2021 through August 15, 2021 for purposes of obtaining
health insurance coverage through the ACA marketplace. The executive order also instructed certain governmental agencies to review and
reconsider their existing policies and rules that limit access to healthcare. More recently, on March 11, 2021, President Biden signed
the American Rescue Plan Act of 2021 into law, which eliminated the statutory Medicaid drug rebate cap, currently set at 100% of
a drug’s average manufacturer price, beginning January 1, 2024.

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In addition, the Budget Control Act of 2011 and
the Bipartisan Budget Act of 2015 led to aggregate reductions of Medicare payments to providers of 2% per fiscal year that will remain
in effect through 2030, unless additional Congressional action is taken. Further, on January 2, 2013, the American Taxpayer Relief Act
was signed into law, which, among other things, reduced Medicare payments to several types of providers, including hospitals, imaging
centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers
from three to five years. More recently, there has been heightened governmental scrutiny over the manner in which manufacturers set prices
for their marketed products, which have resulted in several recent Congressional inquiries and proposed bills designed to, among other
things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform
government program reimbursement methodologies for pharmaceutical products. In August 2022, the Inflation Reduction Act authorized Medicare
to negotiate drug prices for certain high expenditure, single source Medicare part B or D drugs. Individual states in the United States
have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing,
including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure
and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

We expect that additional foreign, federal and
state healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments
will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products,
once approved, or additional pricing pressures.

Coverage and Reimbursement

Significant uncertainty exists as to the coverage
and reimbursement status of any products for which we obtain regulatory approval. In the United States, cosmetics are not generally eligible
for coverage and reimbursement and thus any products that are marketed as cosmetics will not be covered or reimbursed. In the United States
and markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend, in part,
on the availability of coverage and reimbursement from third-party payors. Third-party payors include government authorities, managed
care providers, private health insurers and other organizations. The process for determining whether a payor will provide coverage for
a product may be separate from the process for setting the reimbursement rate that the payor will pay for the product. Third-party payors
may limit coverage to specific products on an approved list, or formulary, which might not include all of the FDA-approved products for
a particular indication. A decision by a third-party payor not to cover our products could reduce physician utilization of our products
once approved and have a material adverse effect on our sales, results of operations and financial condition. Moreover, a payor’s
decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. Adequate third-party reimbursement
may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

In addition, coverage and reimbursement for products
can differ significantly from payor to payor. One third-party payor’s decision to cover a particular medical product or service
does not ensure that other payors will also provide coverage for the medical product or service, or will provide coverage at an adequate
reimbursement rate.

As a result, the coverage determination process
will require us to provide scientific and clinical support for the use of our products to each payor separately and will be a time-consuming
process.

Third-party payors are increasingly challenging
the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and
efficacy. In order to obtain and maintain coverage and reimbursement for any product, we may need to conduct expensive clinical trials
in order to demonstrate the medical necessity and cost-effectiveness of such product, in addition to the costs required to obtain regulatory
approvals. If third-party payors do not consider a product to be cost-effective compared to other available therapies, they may not cover
the product as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow a company to sell its
products at a profit.

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Outside of the United States, the pricing of pharmaceutical
products is subject to governmental control in many countries. For example, in the European Union, pricing and reimbursement schemes vary
widely from member state to member state. Some countries provide that products may be marketed only after a reimbursement price has been
agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular therapy to
currently available therapies or so-called health technology assessments, in order to obtain reimbursement or pricing approval. Other
countries may allow companies to fix their own prices for products, but monitor and control product volumes and issue guidance to physicians
to limit prescriptions. Efforts to control prices and utilization of pharmaceutical products and medical devices will likely continue
as countries attempt to manage healthcare expenditures.

Data Privacy and Security Laws

Numerous state, federal and foreign laws, including
consumer protection laws and regulations, govern the collection, dissemination, use, access to, confidentiality and security of personal
information, including health-related information. In the United States, numerous federal and state laws and regulations, including data
breach notification laws, health information privacy and security laws, including HIPAA, and federal and state consumer protection laws
and regulations (e.g., Section 5 of the FTC Act), that govern the collection, use, disclosure, and protection of health-related and other
personal information could apply to our operations or the operations of our partners. In addition, certain state and non-U.S. laws, such
as the California Consumer Protection Act, the California Privacy Rights Act, and the General Data Protection Regulation, or GDPR, govern
the privacy and security of personal information, including health-related information in certain circumstances, some of which are more
stringent than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating
compliance efforts. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal
penalties and private litigation. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict
with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil
and/or criminal penalties and restrictions on data processing.

Material Agreements

License Agreements

License Agreement with Walter Reed Army Institute
of Research

On
August 24, 2021, APT entered into a Biological Materials License Agreement (or, as modified on August 31, 2022, the WRAIR License Agreement)
with Walter Reed Army Institute of Research or WRAIR, pursuant to which APT received a nonexclusive worldwide license to certain materials
and information, including approximately 100 phage, or WRAIR Materials, to develop and commercialize phage products to treat/prevent Pseudomonas
aeruginosa, Acinebactor baumannii, Staphylococcus aureus, Klebsiella pneumonia,
wound and UTI Escherichia coli and Enterobacter cloacae bacterial infections. The Company uses the phage provided in connection
with the WRAIR License Agreement as a potential source of phage for the development of its phage treatments.

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In connection with the WRAIR License Agreement,
APT paid WRAIR an initial execution fee in the mid-thousands of dollars and agreed to pay a maintenance fee in the mid-thousands of dollars
per year. We are also required to pay royalties expressed as a percentage in the low single digits on net sales of products that incorporate
the WRAIR Materials, or the WRAIR Licensed Products, subject to reductions as described in the WRAIR License Agreement. In addition, if
we sublicense our rights under the WRAIR License Agreement we are obligated to pay WRAIR additional sublicense royalties expressed as
a percentage in the low teens of the sublicensing receipts we receive from any such sublicense royalties. In addition, additional royalties
in the low teens may be assessed on any overdue royalty payments.

We are obligated to make written annual progress
reports to WRAIR, detailing our efforts to bring any inventions licensed under WRAIR License Agreement to the point of practical application,
together with any additional information requested by WRAIR or as contemplated or required under the development plan. As part of our
performance under the WRAIR License Agreement, we have agreed to dose the first patient in a clinical trial with a WRAIR Licensed Product
within four years from the effective date of the WRAIR License Agreement.

In the event WRAIR files a non-provisional patent
application covering the WRAIR Materials and/or the use thereof, provided as part of this License Agreement, WRAIR is obligated to notify
us, and we and WRAIR will assess the need and/or desirability of a patent license. In such case, we will have the first right of refusal
to negotiate a non-exclusive or exclusive license.

The WRAIR License Agreement will expire as to each
WRAIR Material ten years from the date that such WRAIR Material was added to the WRAIR License Agreement unless earlier terminated in
accordance with its terms. We may terminate the WRAIR License Agreement upon 60 days’ written notice, and WRAIR may terminate if
we are in default and such default has not been remedied within 90 days after written notice of such default.

The MTEC Grant Agreement

Industry and academia have entered into a Consortium
Member Agreement to participate in the Medical Technology Enterprise Consortium, or MTEC, a 501(c)(3) biomedical technology consortium
working in partnership with the U.S. Department of Defense, for the purpose of conducting research, development and testing in cooperation
with the U.S. Government in an overall effort to improve Service member health and performance in diverse environments. In 2019, APT entered
into a Base Agreement and Research Project Award, or, collectively, the Research Agreement, with the U.S. Army Medical Research Acquisition
Activity, or USAMRAA, and the U.S. Army Medical Research & Development Command, or USAMRDC, to advance personalized phage therapy
from niche to broad use. Awards under the Research Agreement are intended to lay the groundwork for rapid advancement of personalized
phage therapy to commercialization for the variety of clinical indications and bacterial pathogens representing un-met needs with a focus
on infections with significant military relevance. The competitive award was granted by USAMRAA and USAMRDC in collaboration with MTEC.
Under the cost reimbursement contract, MTEC reimburses APT for approved incurred costs that are based upon the achievement of certain
milestones to support the development of personalized phage therapy. For the period between the acquisition of APT in March 2024 and December
31, 2025, APT received an aggregate of $5.8 million in grants from MTEC.

Employees

As of December 31, 2025, we had 20 full-time
employees. None of our employees is represented by labor unions or covered by collective bargaining agreements. We consider our relationship
with our employees to be strong. As of the date of filing this Annual Report, the Company expects to employ a limited number of key employees
who will remain in order to allow the Company to continue operating at a basic level to best pursue its strategical alternatives.

Corporate Information

We are currently a virtual company. We maintain
a mailing address at 850 New Burton Road, Suite 201, Dover, Delaware 19904, and the telephone number is (972) 545610935. Our corporate
website address is www.biomx.com. The content of our website is not intended to be incorporated by reference into this Annual Report or
in any other report or document we file and any references to these websites are intended to be inactive textual references only.

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